Liebel-Flarsheim Company LLC

Address:2111 EAST GALBRAITH RD.,Cincinnati,OH,45237,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Injector And Syringe, Angiographic (DXT) (9) Injector, Contrast Medium, Automatic (IZQ) (1)

Premarket Exempt

No Yes

Clear

LF - 10746190004110 Catalog Number :

Device Description : OptiStar LE MR Contrast Delivery System, Demo Loan

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004219 Catalog Number :

Device Description : Angiographic Syringe with Filling Spike; fits injectors: Angiomat Illumena and A Angiographic Syringe with Filling Spike; fits injectors: Angiomat Illumena and Angiomat 6000

Device Class :

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004226 Catalog Number :

Device Description : CT Syringe with Filling Spike; for use with OptiVantage, OptiOne, and CT 9000 ADV

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004233 Catalog Number :

Device Description : CT Syringe with Coiled Tubing and Filling Spike; fits injectors: OptiOne, OptiVa CT Syringe with Coiled Tubing and Filling Spike; fits injectors: OptiOne, OptiVantage and CT 9000 ADV

Device Class :

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004240 Catalog Number :

Device Description : CT Syringe with Dual Check Valve Y-Tubing (60”/1500 mm) and Filling Spike; for u CT Syringe with Dual Check Valve Y-Tubing (60”/1500 mm) and Filling Spike; for use with OptiVantage

Device Class :

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004257 Catalog Number :

Device Description : Dual CT Syringe with Y-Tubing (60”/1500 mm) and Filling Spikes; for use with OptiVantage

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004264 Catalog Number :

Device Description : Dual CT Syringe with Dual Check Valve Y-Tubing (60”/1500 mm) and Filling Spikes

Device Class :

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004271 Catalog Number :

Device Description : Angiographic Syringe with Filling Spike; for use with Illumena Neo and Angiomat Illumena

Device Class :

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004288 Catalog Number :

Device Description : Angiographic Syringe with Filling Spike; for use with Illumena Neo and Angiomat Illumena

Device Class :

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

LF - 10746190004318 Catalog Number :

Device Description : OptiOne Single-Head Contrast Delivery System

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

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